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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K801912
Device Name ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
Applicant
ARROW INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ARROW INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/11/1980
Decision Date 09/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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